This study will investigate the efficacy and safety of the monophasic
combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in
healthy fertile Indian women.
Drug: Nomegestrol acetate (NOMAC)
Drug: Estradiol (E2)
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Full eligibility criteria for NCT01723579
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Sexually active and at risk for pregnancy
Of Indian descent, born in India, never emigrated out of India, with Indian home address
Body mass index (BMI) ≥17 and ≤35 kg/m^2
Presence or history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident
Presence or history of prodromi of a thrombosis
History of migraine with focal neurological symptoms
Diabetes mellitus with vascular involvement
Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
Presence or history of pancreatitis associated with severe hypertriglyceridemia
Presence or history of severe hepatic disease
Undiagnosed vaginal bleeding
Known or suspected pregnancy
Currently breastfeeding or breastfeeding within 2 months of starting trial medication
Investigational drug use or participation in another clinical trial within
months of signing Informed Consent Form for current trial
All locations for NCT01723579
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Tris trial is registered with FDA with number: NCT01723579. The sponsor of the trial is Merck Sharp & Dohme Corp. and it is looking for 0 volunteers for the current phase.
Official trial title: An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00
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